FDA UDI
In Commercial Distribution
🇺🇸 United States
Protemp™ II
DI: 04035077001465
·
Model: 46090
·
3M Deutschland GmbH
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Protemp™ II
- Primary DI
- 04035077001465
- Version / Model
- 46090
- Catalog Number
- 46090
- Company Name
- 3M Deutschland GmbH
- Labeler DUNS
- 315731711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-04
- Public Version
- 4
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- c032a8e3-6ef5-4a85-a704-f39d359db201
Device Description
3M™ ESPE™ Protemp™ II Temporization Material Shade A1 Extra Light Refill, 46090
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31783 | Temporary dental crown/bridge | A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. | No | Active |
| 60885 | Dental material cartridge-plunging applicator, two-component, manual | A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04035077001465 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]